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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
July 02, 2017
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.
June 29, 2017
The agency determined additional guidance was needed to reduce regulatory compliance burden.
The agency announced a plan to eliminate its existing orphan designation request backlog.
June 28, 2017
The directorate highlights its 2016 achievements.
June 27, 2017
The agency announced it is taking steps to increase competition within the prescription drug market.
The agency sent a warning letter to Raritan Pharmaceuticals, Inc. after an inspection found quality testing and misbranding violations.
June 26, 2017
Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.
June 23, 2017
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.